artus EBV PCR Kits CE

For quantitative detection of Epstein-Barr virus DNA using real-time PCR

CE-marked IVD workflow (QIAsymphony RGQ)

High reliability using the internal control

Highly sensitive detection of as few as 157 copies/ml (QS-RGQ kit)

Accurate quantitation of viral load over a very broad linear range

artus EBV PCR Kits are ready-to-use molecular detection kits for real-time PCR. The kits provide all necessary reagents optimized for reliable EBV DNA detection and quantitation for in vitro diagnostic use. artus EBV LC, RG, and TM PCR Kits use manual or automated sample preparation and manual assay setup techniques. The artus EBV RG PCR Kit is also available as EASYartus EBV RG PCR Kits, combined with the EZ1 DSP Virus Kit for automated viral nucleic acid purification. The artus EBV QS-RGQ Kit is part of the QIAsymphony RGQ, with an automated workflow from sample to pathogen detection, and is not for use with manual assay setup.

To ensure highest sensitivity, artus EBV Kits have been optimized to detect low numbers of EBV DNA. The analytical sensitivity of the artus EBV QS-RGQ Kit is 157 copies/ml in consideration of the purification from EDTA plasma and assay setup using the QIAsymphony RGQ (see figure "Highly sensitive detection of EBV DNA"). (1.00 copies/ml corresponds to 0.140 IU/ml for detection of EBV DNA in whole blood on the Rotor-Gene Q in combination with automated sample preparation and assay setup using the QIAsymphony RGQ. The conversion factors were established by a regression analysis of multiple dilution series of the 1st WHO International Standard compared against a reference method reporting in IU/ml.)

artus EBV Kits are based on the amplification and simultaneous detection of a specific region of the EBV genome using real-time PCR. The kits provide high levels of specificity, sensitivity (see figure "Highly sensitive detection of EBV DNA"), and reproducibility.

Each artus EBV Kit provides 4 EBV quantitation standards (see figure "Reliable quantitation of EBV load"). Use of the standards enables accurate quantitation of viral load. In addition, the kits contain a second heterologous amplification system to identify possible PCR inhibition. This is detected as an internal control (IC) in a different fluorescence channel from the analytical PCR. The detection limit of the analytical EBV PCR is not reduced.

Specifications of artus EBV RG PCR Kit and artus EBV QS-RGQ Kit

Kit

artus EBV RG PCR Kit

artus EBV QS-RGQ Kit

Validated sample types

Human plasma, CSF, or blood cells

EDTA plasma or whole blood

Amplicon

97 bp region of the EBNA-1 gene

97 bp region of the EBNA-1 gene

Procedure

artus EBV PCR Kits provide all necessary reagents optimized for reliable EBV DNA detection and quantitation. Simply add template DNA to the ready-to-use PCR master mix, and start the reaction on the appropriate real-time cycler using the optimized cycling program described in the kit handbook.

Common temperature profiles for multiple assays in one run

The temperature profile of artus EBV RG PCR Kit and the artus EBV QS-RGQ Kit corresponds to the profiles of the artus RG PCR Kits and artus QS-RGQ Kits for BK virus, CMV, HSV-1/2, and VZV. The temperature profile of the artus EBV LC PCR Kit corresponds to the profiles of the artus LC PCR Kits for HSV-1/2, VZV, and CMV. Therefore, these PCR assays can be performed and analyzed in a single run.

Automated workflow from sample to EBV detection

The QIAsymphony RGQ workflow solution for EBV detection comprises the QIAsymphony SP for sample preparation, the QIAsymphony AS for assay setup, and the artus EBV QS-RGQ Kit on the Rotor-Gene Q. The system enables reliable pathogen detection with a CE-marked IVD workflow (see figure "Integrated QIAsymphony RGQ system for EBV detection").

Recommendations for viral DNA purification when using the artus EBV LC, RG, or TM PCR Kits

artus EBV LC, RG, and TM PCR Kits enable rapid and sensitive detection of EBV DNA from serum, plasma, cerebrospinal fluid (CSF), and blood cells. Kits are available for use on the ABI PRISM 7000, 7700, and 7900HT SDS, on the LightCycler 1.1/1.2/1.5/2.0 Instruments, or on Rotor-Gene Q instruments.

The artus EBV QS-RGQ Kit is validated for use with EDTA plasma or whole blood and is designed to be used with the QIAsymphony RGQ system, providing a CE-marked IVD workflow from sample to EBV DNA detection and quantitation.